Description

Apremilast Impurity 18 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Apremilast during development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and quality control laboratories involved in the production and regulatory compliance of Apremilast-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Apremilast API and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to monitor and control impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Apremilast meets stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines for impurity profiles.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Facilitates studies on the degradation pathways, metabolism, and pharmacokinetics of Apremilast.

Basic Information

Product Name	Apremilast Impurity 18
CAS No.	1407140-51-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apremilast Related Compound 18; Apremilast Impurity 18 (1407140-51-5); Apremilast EP Impurity I; Apremilast USP Impurity 18; 2-[(1S)-1-[3-Ethoxy-4-methoxyphenyl]-2-(methylsulfonyl)ethyl]-4-acetylaminoisoindoline-1,3-dione (Proposed); Otezla Impurity 18; CC-10004 Impurity 18
EINECS	Contact for details

Quality Control

Every batch of Apremilast Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA), detailing all test results and methods, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Assay (HPLC)	95.0% - 105.0%
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.